This was a prospective, non-randomized, open-label observational study conducted in Germany over two years.The purpose of the study was to evaluate the use, safety and effectiveness of black cohosh alone or in combination with St. John's wort on menopausal symptoms.

6141 women at 1287 outpatient gynecology offices were treated with recommended doses of Remifemin (an isopropanol extract of black cohosh), 1 cap bid, or Remifemin in combination with St. Johns wort, 1 or 2 tablets bid, at the discretion of the clinician.

Of the enrolled women, 3027 received the black cohosh only, and 3114 received the black cohosh/St. John's wort combination.During the study, 244 women changed treatment from monotherapy to the combination product, and 87 women changed from the combination product to monotherapy.

The differences in baseline symptoms between the two treatment groups indicate different indications for use. Prior to treatment, the women receiving the combination therapy had significantly worse psychological symptoms than those in the black cohosh only group.The symptoms in both groups were mostly mild to moderate and mostly included hot flushes, sleep disorders, nervousness and depressive mood, which were moderate in severity.

The symptom scores improved in both groups.The changes in the psychological symptoms were greater in the combination therapy group than in the black cohosh only group at months 3 and 6. With both treatments, the greatest effects were seen with hot flashes and night sweats.Improvements in symptoms were evident at month 3, and were greater at month 6.

Both treatments were very well tolerated.The rate of adverse events related to the treatments was very small, at 0.16% or 10 cases.Seven cases were in the black cohosh only group and three were in the combination group.

Commentary:The results from this large study support the effectiveness of black cohosh preparations alone or in combination with St. John's wort for relief of common menopausal symptoms such as hot flushes, nightsweats and psychological symptoms.The combination of the two herbs appears to be the best approach for menopausal symptoms that include depressive moods, nervousness, irritability, and impaired memory.

Sixty postmenopausal women were randomized in a crossover trail to either a therapeutic lifestyle changes (TLC) diet alone or a similar TLC diet which included one-half cup soy nuts containing 25 grams of soy protein and 101 mg of isoflavones, divided into 3-4 doses throughout the day.For each 8-week time period, study subjects recorded the number of hot flashes.

In women with more than 4.5 hot flashes per day, the TLC diet plus soy nuts was associated with a 45% decrease in hot flashes, when compared to the TLC diet alone.With treatment, there were 4.1 hot flashes per day in the TLC plus soy nut group vs. 7.5 hot flashes per day in the TLC diet alone group.Soy nuts were also associated with a significant improvement in other menopausal quality of life issues including psychosocial symptoms.

Commentary:Numerous previous studies have shown inconsistent reductions in menopausal symptoms with soy preparations, whether it be soy foods, soy beverage, soy powders or soy isoflavone capsules/tablets.This study suggests that the complex of the whole soybean with its significant soy protein and isoflavone content is responsible for the improvements in symptoms, which weren't seen in other studies using processed soy products.

The prevalence of BV was 41.8% and severe BV, 14.9%.Both BV and severe BV were significantly more prevalent in African-Americans than in Caucasians.

After adjusting for demographic and behavioral variables, total energy intake was 50% higher in those with BV, yet still only marginally associated with BV.Only total fat intake was significantly associated with BV.Total fat, saturated fat and monounsaturated fat intakes were significantly associated with severe BV.Protein intake was significantly inversely associated with severe BV.

There were significant inverse associations between severe BV and the intakes of folate, vitamin E and calcium.When the 17.6% of women who had persistent BV were compared with the 15.2% who had remitting BV, none of the macro- or micronutrients was significantly associated with the overall incidence of BV

Commentary:This was the first study that I have seen that has evaluated the relationship between BV and total nutritional intake.In this study, total fat intake was a significant predictor of BV. The risk of severe BV was more than twice as high in women who were in the highest quartile of intakes of total fat, saturated fat and monounsaturated fat.

Previous studies that looked at the relationship between BV and specific micronutrients such as vitamins C and A have shown no significant association.In the current study, the most striking finding was the relationship between dietary fat and BV.The mechanism for this is unclear but a high fat intake, especially saturated fat, may alter vaginal microflora and increase vaginal pH, which would then increase the risk of BV.Another possible mechanism may be explored by looking at the role that high fat intake has on intestinal mucosa.We have other evidence that high fat intake modulates immune function in the intestinal mucosa.It is plausible then that high dietary fat intake may affect the mucosal immune system in other parts of the body, such as the vagina, and by doing so, may increase the risk of BV.

About Me

I'm an organic gynecologist, yoga teacher + writer. I earn a living partnering with women to get them vital and self-realized again. We're born that way, but often fall off the path. Let's take your lousy mood and fatigue, and transform it into something sacred and useful.

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Sara Gottfried, MD

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